CLIA - Clinical Laboratory Improvement Amendments

1 to 10 of 41 Results
Analyte Hemoglobin Complexity waived

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Document	Analyte	Analyte Specialty	Effective Date
Avie Total Hb Test System {Professional Use}
K121752	Hemoglobin	Hematology	01/07/2013
Bayer A1C Now SelfCheck
K090413	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	05/30/2012
Bayer A1CNow + Professional Use
K051321	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	05/30/2012
Diaspect Hemoglobin Measuring System
BK110036	Hemoglobin	Hematology	04/05/2012
Alere HemoPoint H2 Hemoglobin Measurement System
K081719	Hemoglobin	Hematology	10/05/2011
Stanbio HemoPoint H2 DM Hemoglobin Measurement System {with Data Management}
K090093	Hemoglobin	Hematology	06/12/2009
MEC Dynamics Avie A1c Test System
K081269	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	04/01/2009
Abbott i-STAT 6+ Cartridge (Venous Whole blood)
K053110	Hemoglobin	Hematology	11/13/2008
Abbott i-STAT E3+ Cartridge (Venous Whole blood)
K053110	Hemoglobin	Hematology	11/13/2008
Abbott i-STAT EC4+ Cartridge (Venous Whole blood)
K053110	Hemoglobin	Hematology	11/13/2008